Masterclass: Digital Health Regulatory Updates

As we move into 2024, the digital health policy landscape is evolving dramatically. The digital health industry is revolutionising healthcare delivery, but navigating the ever-changing regulatory landscape can be daunting. 

From the FDA's pioneering Clinical Decision Support Software Guidance, aligning more closely with White House policies and removing all references to IMDRF risk stratification, to the European Union's implementation of the Medical Device Regulation (MDR), which imposes stricter requirements on medical device manufacturers, these developments shape the landscape for innovation and market access. Additionally, FDA published the Refuse to Accept Policy for Cyber Devices, as part of Section 524B of the FD&C Act. Lastly, the AI Bill of Rights has been released by the White House in 2023. 

This roundtable aims to empower you with the latest regulatory updates and equip you to make informed decisions for your digital health product or service.

Join our interactive discussion as we explore critical questions surrounding the evolving regulatory landscape:

• What are the latest updates from FDA and how they impact the development and approval process for digital health solutions?

• How to leverage the Clinical Decision Support Software Policy within your product development lifecycle?

• What the Predetermined Change Control Plan Policy is and how to incorporate it into your product development lifecycle?

• Can emerging technologies like AI and AR navigate the current regulatory framework, and what are the potential roadblocks?

We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.